Immunologic and Antibody Responses in Patients Receiving GM-CSF, (Leukine, Sargramostim) as Adjuvant Therapy of Stage II (T4), III and IV Melanoma.
This is a pilot study to describe the immunological responses and clinical outcome
associated with administration of recombinant human Granulocyte Macrophage Colony
Stimulating Factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma
who are at high risk for recurrence (Stage II T4, III and IV). The immunological responses
include serum neopterin levels. In a sub-set of study participants, additional immunologic
testing will be done, including monocyte cytotoxicity to a melanoma cell line and phenotypic
and functional markers of dendritic and T cell activation in peripheral blood mononuclear
cells. The clinical end points of the study include safety, time to disease recurrence,
time to disseminated disease, and survival. Eligible patients are those with high-risk
melanoma who are clinically tumor free following surgery. Treatment will consist of GM-CSF
at 125 g/m2 once daily (maximum dose 250 g) for 14 days followed by 14 days of rest (28
day cycle) for 1 year. Clinical status will be monitored until death or until the patient
has been tumor free for five years, whichever event occurs first. Immunologic responses
will be determined pretreatment, at the end of the first 14 days of dosing (Day 15), after
the 14-day rest period (Day 29) and at the end of 14 days of dosing in cycles 6 (Day 155)
and 13 (Day 351). Clinical outcome will be determined according to patient risk group
(ultra-high risk Stage IIIC or IV versus high-risk Stage II T4, Stage IIIA and Stage IIIB).
The pilot study will also assess the association of the immunological responses with
clinical response and safety by patient risk group.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1 To describe the effect of GM-CSF adjuvant treatment of 125 ug/m2 once daily for 14 days followed by 14 days rest on immunological function as determined by serum neopterin levels (a measure of macrophage activation) and on serum levels of S100B.
Lynn E. Spitler, MD
Northern California Melanoma Center
United States: Institutional Review Board
|Northern California Melanoma Center||San Francisco, California 94109|